ISO IDMP – Building your business case through Master Data Management and integral IDMP

12 October 2016

At this free webinar we discussed how to build a business case for IDMP implementation through Master Data Management (MDM) and an integral approach to IDMP, which in combination can release other business benefits in your organization than mere compliance. 

As EMA’s deadlines are drawing closer, IDMP’s profound impact on the management of regulatory data becomes clearer and clearer. Going from xEVMPD to IDMP, the data will come from sources beyond Regulatory Affairs such as CMC, Clinical, PV, and Manufacturing. As a consequence, data integrity and data quality across these business areas will have to be in absolute control.

At this webinar we discussed how to build a business case for IDMP implementation through Master Data Management (MDM) and an integral approach to IDMP, which in combination can release other business benefits in your organization than mere compliance. The webinar highlighted how to get from the initial IDMP data analysis to an iterative and modular MDM approach that will strengthen transparency throughout the business areas. The webinar discussed how to set up a master data governance structure that oversees the relevant processes touched by IDMP and assigns data ownership with the right timing.

Moreover, the webinar presented how IDMP compliance and business benefits are supported by an integral approach to IDMP, which is also an enabler of the Master Data Management. To illustrate this, the webinar presented Amplexor’s ISO IDMP compliant ProductExpert module pre-release. This technology is part of the Integral by Design, Modular by Implementation™ product suite that, combined with the myIDMPJourney™ approach, supports the transition to IDMP EMA Iteration 1 compliance and is ready for any subsequent HA’s IDMP implementations. 

Agenda

IDMP business case and master data management:

  • Building a business case
  • Potential business benefits of IDMP
  • From data analysis to MDM
  • Initiating data ownership

Technology to deal with IDMP:

  • Integral vs. Integrated – where is the difference?
  • Integral IDMP as part of Next Generation RIM
  • Integral IDMP as Master Data Management enabler
  • Integral IDMP – opportunities for the future
  • Integral IDMP in integral Cloud    

Speakers

Niels Buch Leander, Global RA Lead, Managing Consultant, NNIT

Niels Buch Leander, Ph.D., is a Managing Consultant and Global Regulatory Affairs Lead in NNIT. His specialization is R&D IT Strategy and data analysis in relation to document management, product information and regulatory data standardization, which he has worked with since 2008. He has been working with the ISO IDMP standards since 2013 and been involved in numerous IDMP projects in Europe and the US.

Romuald Braun, Vice President Strategy, Amplexor Life Sciences

Since 1992 Romuald has been working in roles related to Compliance, Document Management, Content Management in the Life Sciences industry. Romuald has been playing roles on the client side and in consulting, in delivery and in sales, in project roles and in line responsibility. He worked in client server and in cloud environments, in Europe and in US. Romuald is holding the academic degree of Master of Drug Regulatory Affairs in addition to his Engineer diploma in Data Technology. Romuald has been also a frequent speaker on topics relating to content management adoption in Life Sciences.